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National Biotechnology Authority Bill, 2005 (HB 11, 2005)
February 17, 2006

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National Biotechnology Authority Bill, 2005

MEMORANDUM

This Bill establishes the National Biotechnology Authority, a statutory body which will be responsible for managing the import, research, development, production, use and release of all biotechnology techniques, processes and products, ensuring that such activities do not cause adverse effects on health, the environment, the economy, national security and social norms and values. In more detail the Bill provides as follows:

Part I of the Bill deals with preliminary matters, i.e. the title of the Bill, date of commencement and the interpretation of terms.

In Part II of the Bill, clause 4 provides for the establishment of the National Biotechnology Authority which will be a body corporate with the usual features of such corporations. Clause 5 details the functions of the Authority. Central to these functions is to regulate, supervise, co-ordinate, promote and develop biotechnology having regard to the need to maintain safety in the import, export, or manufacture or processing of any biotechnology product. The Authority will be responsible for advising the Minister on matters of national policy in biotechnology..
Clause 6 constitutes a board which will be entrusted with directing and controlling the affairs of the Authority.
Clause 7 sets out the general disqualifications for appointment as members of the Board and persons who already serve as members of two or more statutory bodies will not qualify as members of the Board. Clauses 8 to 17 are standard provisions dealing with conditions of service of members of the Board, committees of the Board, the holding of meetings and the appointment of the chief executive, etc. Clause 18 provides for the appointment and functions of a chief executive officer. Clause 20 requires the Authority to submit reports to the Minister and the Minister may give directions on matters of policy to the Board (clause 21).

Part III of the Bill makes provision in clause 22 for the control and monitoring of use of products of biotechnology. Of importance is the issuing by the Board of biotechnology guidelines and standard procedures which are binding on all users of product of modern biotechnology. The Board will also establish a register for the purpose of registering facilities utilised for the development, production or use of biotechnology (clauses 23-25). Furthermore, the Board shall appoint inspectors whose main purpose is to inspect any activity or process carried out in or upon premises in connection with the use of any product of biotechnology.

Part IV of the Bill makes provision in clause 30 for the establishment of biosafety committees, which shall ensure that any biotechnology guidelines or standards and the terms and conditions of registration are complied with by all persons engaged in biotechnology research, development and application. Every project at each biotechnology research institute shall be monitored by a project supervisor.

Part V of the Bill makes provision in clause33 for the appointment of inspectors of the Authority.

Part VI of the Bill makes provision in clauses 34-42 for the management of the financial affairs of the Authority. Significant is clause 34 under which the main source of the funds of the Authority will include Parliamentary appropriations and grants from the Fund as may be determined by the Minister. The rest of the provisions in this Part are standard.

Part VII of the Bill provides in clauses 43 to 48 for the National Biotechnology Fund. Clause 43 establishes the Fund which will be vested in the Minister as trustee. Central to the objects of the Fund is to promote the marketing and production of, stimulate demand for, research into modern biotechnology. It will also be the purpose of the Fund to ensure that personnel are appropriately trained to fulfil the objects of the Fund and the Authority. Under clause 44, the Fund will consist mainly of levies which will be collected in terms of this Bill and of Parliamentary appropriations. Under clause 45, the Fund will be administered by the Authority on behalf of the Minister and in accordance with instructions given by the Minister. Clause 46 sets out the purposes to which the Fund will be applied. Grants will be made to the Authority from the Fund for the purposes of the functions of the Authority. The Fund will also be applied to meet its objects as set out in clause 44. The cost of administering the Fund will also be met out of the Fund. The financial year of the Fund will be the same as that of the Authority (clause 47) and the Authority will maintain its accounts. The Fund will be audited by the Comptroller and Auditor General in terms of the Auditor and Exchequer Act [Chapter 22:03].

Part VIII of the Bill provides for the imposition of levies under clauses 49 to 51. Under clause 49, the Minister is authorised, for the benefit of the Fund, to impose levies on producers, processors and/or buyers of any product of biotechnology. The details as to how this will be carried out will be prescribed in a statutory instrument to be made by the Minister. Clause 50 provides for the suspension or increase of levies as may be necessary and clause 51 requires that consultations with organisations of producers, processors and buyers of products of biotechnology be held before the imposition, withdrawal, suspension or increase of levies. Failure to pay a levy will be an offence (clause 52) and outstanding levies will be a debt to the Fund, attracting interest or a surcharge and may be sued for in court (clause 53). Clause 54 grants the Minister additional powers regarding the imposition or increase of a levy for a period of six months, and the manner in which this must be done, in the event of an emergency in the biotechnology industry.

Part IX of the Bill deals with general matters pertaining to confidentiality on information acquired in the exercise of functions in terms of this Bill and payment of fees for registration in relation to foreign research. Clause 58 provides for appeals against decisions of the chief executive and the Board to the Minister and the Administrative Court. Clause 59 provides for the Minister’s powers, in consultation with the Board, to make regulations on a wide range of matters relating to the implementation of this Bill. Clause 60 provides for the repeal of The Research (Biosafety) Regulations, 2000, published in Statutory Instrument 20 of 2000.

National Biotechnology Authority Bill, 2005

Arrangement of Sections

PART I
PRELIMINARY

Section

1. Short title and date of commencement.
2. Interpretation.
3. Application of Act.

PART II
NATIONAL BIOTECHNOLOGY AUTHORITY
4. Establishment of Authority.
5. Functions and powers of Authority.
6. Board of Authority.
7. Disqualifications for appointment as member.
8. Terms and conditions of office of members.
9. Vacation of office by appointed members.
10. Suspension of appointed members of Board.
11. Filling of vacancies on Board.
12. Meetings and procedure of Board.
13. Committees of Board.
14. Remuneration and allowances of members of Board and committees.
15. Disclosure of interests by members of Board and committees.
16. Minutes of proceedings of Board and committees.
17. Validity of decisions and acts of Board and committees.
18. Appointment and functions of Chief Executive Officer of Authority.
19. Execution of contracts and instruments by Authority.
20. Reports of Authority.
21. Minister may give Board directions on matters of policy.

PART III
CONTROL AND MONITORING OF BIOTECHNOLOGY
22. Power of Board to regulate biotechnology practices.
23. Register of facilities and permits.
24. Certain facilities and research to be registered or permitted.
25. Application for and grant or refusal of registration or permission.
26. General duty of care to be observed by users of products of biotechnology.
27. Notification of releases and accidents.
28. Returns to be furnished by registered users.

PART IV
BIOTECHNOLOGY COMMITTEES
29. Interpretation in Part IV.
30. Biosafety Committees.
31. Project supervisors.

PART V
INSPECTORS OF AUTHORITY
32. Appointment and functions of inspectors.
33. Inspections.

PART VI
FINANCIAL PROVISIONS RELATING TO AUTHORITY
34. Funds of Authority.
35. Investment of moneys not immediately required by Authority.
36. Financial year of Authority.
37. Accounts of Authority.
38. Audit of Authority’s accounts.
39. Powers of auditors.
40. Authority to make certain charges to revenue account.
41. Establishment and operation of general reserve.
42. Meeting of deficiencies.

PART VII
BIOTECHNOLOGY FUND
43 Establishment and object of Fund.
44. Composition of Fund.
45. Administration of Fund.
46. Application of Fund.
47. Financial year of Fund.
48. Books of account and audit of Fund.

PART VIII
LEVIES
49. Imposition of levies.
50. Withdrawal, suspension or increase of levies.
51. Consultation and approval required for imposition, withdrawal, suspension or increase of levies.
52. Failure to pay, collect or remit levies.
53. Recovery of unpaid levies
54. Minister’s powers in respect of levies in case of emergency.

PART IX
GENERAL
55. Conflicts of interests.
56. Confidentiality.
57. Fees for registration or permission in relation to foreign research.
58. Appeals.
59. Regulations.
60. Repeal of regulations made under Part VA of Cap. 10:22
SCHEDULE: Powers of Authority.

Presented by the Minister of Science and Technology Development

BILL

To establish the National Biotechnology Authority whose function shall be to support and manage biotechnology research, development and application; to provide for the constitution of a board of the Authority; to provide for the establishment of the National Biotechnology Fund for the development of the products of biotechnology; to provide for the fixing of standards of quality and other matters relating to products of biotechnology produced in Zimbabwe; and to provide for matters connected with or incidental to the foregoing.

ENACTED by the President and the Parliament of Zimbabwe.

1 Short title and date of commencement
(1) This Act may be cited as the National Biotechnology Authority Act [Chapter 14:31].
(2) This Act shall come into operation on a date to be fixed by the President by statutory instrument.

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